Multiple Organ Dysfunction SyndromeMC MonitorNCT02246036
Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation
A study testing APD probe in people with Multiple Organ Dysfunction Syndrome, run by Advanced Perfusion Diagnostics at 3 sites in France.
Trial summary
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Organ Dysfunction Syndrome
- What is being tested?
- APD probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or more,
- Male or female,
- ICU patient, on vasoactive amines, under mechanical ventilation,
- Stable hemodynamic status,
- Life expectancy expected to exceed 72 hours,
- Length of ICU stay greater than 5 days,
- Willing to participate and signed informed consent,
- Affiliation to the French social security system.
Who cannot join
- Pregnant or lactating woman,
- Ongoing enteral nutrition,
- Risk of gastrointestinal ischemia,
- History of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal area,
- Known ear-nose-throat malignant disease,
- Unexplored dysphagia,
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- Known recent gastrointestinal suture,
- Esophageal varices,
- Abdominal pain,
- Unstable cervical fracture,
- Moribund patient,
- Active participation in another investigational protocol within the past 30 days,
- Subject legally protected, under legal guardianship, deprived of his/her liberty by judicial or administrative decision.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Estaing - Service réanimation adultes
Clermont-Ferrand, 63003
Centre Hospitalier Lyon-Sud
Lyon, 69310
GHU Caremeau - Unité REA
Nîmes, 30900
About this study
Official title: Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.
Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).
Read more
"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.
The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.
The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.
- Conditions
- Multiple Organ Dysfunction Syndrome
- Being tested
- APD probe
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD probeDevice
The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).
| Study group | Role | What they receive |
|---|---|---|
| APD probe | Experimental | Placement of a duodenal probe during 24 hours. Receives: Device: APD probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of duodenal lesions
Duodenal lesions are defined as visible alterations of the duodenum.
Measured: 24 hours
Secondary outcomes (1)
Signal-to-noise ratio of the APD probe
The signal is a reflect of the pulsatile flow in the duodenum. This assertion is evaluated thanks to a signal-to-noise ratio of the cardiac frequency in the PPG on other non-filtered signal componants.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Perfusion Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- Bernard Allaouchiche, Prof., Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246036
- Sponsor's protocol ID
- 2014-A00989-38
- Acronym
- MC Monitor
- Status last verified
- Oct 2016
- First submitted
- 18 Sep 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT02246036
- Acronym / sponsor ID
- MC Monitor / 2014-A00989-38
- Conditions
- Multiple Organ Dysfunction Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Advanced Perfusion DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.
Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).
"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.
The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.
The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APD probe | Experimental | Device: APD probePlacement of a duodenal probe during 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or more,
- Male or female,
- ICU patient, on vasoactive amines, under mechanical ventilation,
- Stable hemodynamic status,
- Life expectancy expected to exceed 72 hours,
Key exclusion criteria (13 listed)
- Pregnant or lactating woman,
- Ongoing enteral nutrition,
- Risk of gastrointestinal ischemia,
- History of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal area,
- Known ear-nose-throat malignant disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APD probeThe probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). | Device | APD probe |
Primary outcome
Absence of duodenal lesions
Time frame: 24 hours
Duodenal lesions are defined as visible alterations of the duodenum.
1 secondary outcome
Signal-to-noise ratio of the APD probe
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Allaouchiche, Prof. principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APD probe in people with Multiple Organ Dysfunction Syndrome, run by Advanced Perfusion Diagnostics at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of duodenal lesions (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.